EU MDR - More then Just Red Tape?

In this episode of the NEW Device and Conquer podcast, Michelle and co-host Ti dive deep into the European Union’s Medical Device Regulation (MDR) — and explain why it’s much more than just red tape.

The conversation begins with a fun recap of their “Real or Ridiculous” game, where they fact-check quirky device ideas like smart spoons for Parkinson’s, mood rings that claim to detect cancer, and next-gen implants.

From there, they unpack the real-world implications of MDR, explaining what the regulation means for companies, innovators, and ultimately, patients.

(MDR content starts at 7:06 if you don't want to listen to "Real or Ridiculous")

Key highlights include:

• The challenges and importance of achieving a CE mark under MDR

• How MDR impacts both startups and established medtech companies

• The balance between innovation and compliance in Europe’s regulatory landscape

• Practical insights on how companies can prepare for MDR scrutiny

• The ripple effect on global markets, investors, and patient safety

Whether you’re a regulatory affairs professional, a medical device startup, or just curious about how Europe is shaping the future of healthcare innovation, this episode breaks down complex regulations into an engaging and accessible conversation.

Tune in to learn why MDR is reshaping the medtech industry — and how you can stay ahead.

Watch the video version on YouTube: https://youtu.be/lJIGfF4wECQ